The subsequent document represents a memorandum I crafted as a recommendation addressed to the Acting Commissioner of the Food and Drug Administration of the United States (at that time). It was prepared for my Public Policy Process class at Georgetown University during the Fall of 2019, under the guidance of Professor Lynn Ross, who served as the Executive Assistant of the Immediate Office of the Commissioner.

Memorandum

To: Norman E. Sharpless, Acting Commissioner, Food and Drug Administration
From: Digvijay Ghotane, Executive Assistant, Immediate Office of the Commissioner
Date: 26 September, 2019
Subject: Strengthening E-Cigarette Regulations for a Safer & Healthier America – Cases & Recommendations

Recommendation

About your meeting with current Administration strategists later during the day, I would strongly urge you to take a stand toward the strengthening of electronic cigarette regulations. Nicotine, the primary substance found in e-cigarettes is highly addictive^[1]. The primary concern is the extensive use of e-cigarettes by the youth today, especially by underage audiences^[2]. This is primarily due to extensive advertising of e-cigarettes that is knowingly or unknowingly targeting a younger audience^[3]. Yet another concern is the adverse effect e-cigarettes have on one’s health, specifically the severe pulmonary diseases developed by people in recent times, as reported by the CDC^[4]. There are also insufficient federal standards for the manufacturing of e-cigarette devices, leading them to explode or be a fire hazard^[5]. Hence, I’d urge you to take this stand^[6] which is on the same tangent as the policy of the current administration^[7]; also in conjunction with public opinion^[8].

Introduction

Today, the issue surrounding the loose legislation or the lack thereof, for the use, sales and marketing, and manufacturing of electronic cigarettes is alarming. The current administration is in support of strengthening the legislation that surrounds e-cigarettes primarily for the safety of the public^[9]. E-cigarettes were introduced into the US market around 2006-07^[10]. Since their introduction e-cigarette sales have skyrocketed to $10.2B in 2018^[11]. The use of e-cigarettes by middle and high school students has increased considerably, from 3.6M in 2017 to 4.9M in 2018^[12]. This has ought to raise concern amongst parents and teachers of such youngsters^[13]. A descriptive study^[14] has found out that marketing practices for e-cigarettes may be targeted toward the youth, especially with the availability of flavors that are attractive to the younger crowd^[15]. Moreover, the recent reports about health issues and even deaths linked to vaping have drawn public attention toward e-cigarettes^[16]. Other reasons also include the lack of legislation for issues of manufacturing of electronic cigarettes which is leading to the lithium-ion batteries in the e-cigarettes to explode. The other side can argue that e-cigarettes offer a potential benefit to people who are trying to quit smoking, but there is no direct evidence linked to it^[17]. Tobacco companies themselves have also lobbied for legislation to be enacted in certain states also known as the ‘Tobacco 21’ campaign^[18]. Thus, it is necessary to regulate e-cigarettes^[19].

Key Issues

• Use by Youth

The CDC as well as the FDA has pointed out the extensive use of e-cigarettes amongst young students especially high and middle school going kids. Originally developed to help people quit smoking traditional cigarettes, this may also lead to youth smoking cigarettes after starting with e-cigarettes. Parents and teachers are worried about this problem that the FDA calls an ‘epidemic^[20].’ This calls for action^[21] not only because of the indicators in the form of numbers that suggest high use by the youth but also because of the national mood. The laws concerning the marketing of e-cigarettes are non-existent which means companies can freely advertise to anyone at the moment, which is a problem. Especially certain e-cigarette companies like JUUL marketing their product safer than cigarettes is also a big concern^[22].

• Health Effects

Recent reports^[23] have shown that people are developing pulmonary diseases that are linked to the use of electronic cigarettes. Little research on the safety of e-cigarettes coupled with the enforcement discretion allowance (without FDA approval) for the sale of e-cigarettes and the liquid cartridges leads to a problem that we see as a focusing event right now, i.e. people dying due to lung disease.

• Lack of Federal Standards

There is a lack of federal standards when it comes to the sale of e-cigarettes and their cartridges, the manufacturing of the electronic cigarette itself, and the marketing of e-cigarettes. Currently, e-cigarettes that are in the market can be sold without assessing their safety until May 2020^[24]. The safety standards for the manufacturing of the devices themselves are next to non-existent which makes it a huge safety concern with the devices exploding or even catching fire^[25].

Recommendations

My recommendations for the problems would include increasing the costs of electronic cigarettes and their cartridges such that the youth does not have easy access to them. Another way would only allow people who want to quit smoking traditional cigarettes to acquire a vaping device or e-cigarette via a prescription^[26]. Raising the federal age to 21, as lobbied by interest groups in many states would lead us to be in an advantageous position. Curbing the marketing of such products that are aimed at the younger generation is of utmost importance. Educational campaigns^[27] that raise awareness about nicotine addiction and the dangers associated with e-cigarette use would likely prove beneficial.

I would urge you to move forward with the already existing 2016 regulations. At the same time, working for legislation that is similar to the Tobacco Master Settlement Agreement (MSA) concerning compensation of medical costs to states for e-cigarette related illnesses from the current market competitors. My final recommendation would be to work on legislation that would allow safer manufacturing standards for e-cigarettes as well.

Conclusion

All in all, I would urge you to push for this agenda at the moment owing to various reasons pointed out before. In my belief, the time for this policy has come^[28]. Keeping in mind the facts, the numbers pointing out to the underage youth extensively using e-cigarettes, the focusing events on the pulmonary diseases and deaths linked to e-cigarettes, the lobbying by interest groups in various states, and the current national mood especially that of parents and teachers, while also keeping in mind the goal of security and safety of the people, this policy decision is the one that the current administration should undertake^[29].

References

1. Centers for Disease Control and Prevention, Data and Statistics, Fast Facts and Fact Sheets, Quitting Smoking, https://www.cdc.gov/tobacco/data_statistics/fact_sheets/cessation/quitting/index.htm
2. Surgeon General's Advisory on E-cigarette Use Among Youth, https://e-cigarettes.surgeongeneral.gov/documents/surgeon-generals-advisory-on-e-cigarette-use-among-youth-2018.pdf
3. Cigarettes Can't Be Advertised On TV. Should Juul Ads Be Permitted?, https://www.npr.org/sections/health-shots/2019/08/20/752553108/cigarettes-cant-be-advertised-on-tv-should-juul-ads-be-permitted
4. CDC, FDA, States Continue to Investigate Severe Pulmonary Disease Among People Who Use E-cigarettes, https://www.cdc.gov/media/releases/2019/s0821-cdc-fda-states-e-cigarettes.html
5. Rachel Becker, “Deadly vape explosion highlights safety gaps,” The Verge, Feb. 5, 2019, https://tinyurl.com/ych8p4jc; “No smokescreen: Shedding light on e-cigarette safety,” UL, Aug. 11, 2018, https://tinyurl.com/yy82qh8j
6. Agendas, Alternatives, and Public Policies, Second Edition, John W. Kingdon, with new foreword by James A. Thurber, pg. 79, para. 2 - The current administration is on the same page with the issue, and with the current information, this can be an instance of incrementalism by improving legislation one step at a time since steps are already been taken by the Food and Drug Administration in the recent past.
7. Trump Administration Plans to Ban Flavored E-Cigarettes. https://www.nytimes.com/2019/09/11/health/trump-vaping.html
8. Agendas, Alternatives, and Public Policies, Second Edition, John W. Kingdon, with new foreword by James A. Thurber, pg. 66, para. 4 - Public opinion affects the agenda, and the current public opinion especially by parents and teachers is that of against e-cigarettes.
9. Policy Paradox, The Art of Political Decision Making, Revised Edition, Deborah Stone, pg. 94, para. 3 - The safety of people or polis, I believe in this case is the goal of the current administration.
   
   Stone speaks about the dimensions of need, in specific the fourth dimension, that is the prevention of future needs, that would in this case not only be trying to reduce the number of people addicted to nicotine in the future but also trying to prevent diseases that people may develop as seen recently, but it may be at the cost of liberty of the people to decide what is right or wrong for them.
10. A Historical Timeline of Electronic Cigarettes, para. 7, http://www.casaa.org/historical-timeline-of-electronic-cigarettes/
11. E-cigarette And Vape Market Size, Share & Trends Analysis Report By Distribution Channel (Online, Retail), By Product, By Component, By Region, And Segment Forecasts, 2019 - 2025, https://www.grandviewresearch.com/industry-analysis/e-cigarette-vaping-market
12. Progress Erased: Youth Tobacco Use Increased During 2017-2018, Center for Disease Control and Prevention, para. 1, https://www.cdc.gov/media/releases/2019/p0211-youth-tobacco-use-increased.html
    
    Policy Paradox, The Art of Political Decision Making, Revised Edition, Deborah Stone, pg. 163, para. 1 - Stone talks about numbers being a common way to define a policy problem and in this case, the number of high and middle schoolers using e-cigarettes is a very good way to point out the problem in the current policy.
13. Agendas, Alternatives, and Public Policies, Second Edition, John W. Kingdon, with new foreword by James A. Thurber, pg. 146 - The national mood could possibly be around the harm e-cigarettes are bringing to the American society at large, hence, the current administration also is swaying toward the same sensing the environment and making statements such that enough attention is garnered by the government toward a condition that the polis feels is a problem.
14. Are Electronic Cigarettes Marketed Towards Youth? Results from a Descriptive Study, https://pediatrics.aappublications.org/content/142/1_MeetingAbstract/451
15. Agendas, Alternatives, and Public Policies, Second Edition, John W. Kingdon, with new foreword by James A. Thurber, pg. 101, para. 4 - This is an example of a feedback wherein it was found out that the advertisements were projected in such a way that they may be targeted toward a younger audience, which can be explained by the spike in sales and the rise in use by middle and high schoolers.
16. Agendas, Alternatives, and Public Policies, Second Edition, John W. Kingdon, with new foreword by James A. Thurber, pg. 94, para. 4 - Kingdon speaks about focusing events, and in this case people dying and being affected by lung related diseases is a focusing event here where regulations around e-cigarettes and other vaping devices garnered a lot of public attention, along with the attention of the government.
17. Electronic Cigarettes, What’s the Bottomline?, https://www.cdc.gov/tobacco/basic_information/e-cigarettes/pdfs/Electronic-Cigarettes-Infographic-508.pdf
18. A Flurry of States Have Raised Their Smoking Ages. But Big Tobacco’s Involvement Has Some Health Groups Uneasy, https://time.com/5593618/vaping-tobacco-21-laws/
    
    Agendas, Alternatives, and Public Policies, Second Edition, John W. Kingdon, with new foreword by James A. Thurber, pg. 49, para. 3 - Interest group pressure is something that influences the agenda according to Kingdon and is very important in agenda setting, in this case, the interest group Big Tobacco along with others lobbied for a legislation to prevent sale of tobacco products to someone below the age of 21.
19. Agendas, Alternatives, and Public Policies, Second Edition, John W. Kingdon, with new foreword by James A. Thurber, pg. 90 - Kingdon talks about conditions becoming problems, I believe that the conditions here have turned into problems due to indicators (numbers), focusing events (lung disease & deaths) and feedback (advertisements).
20. Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use, https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-steps-address-epidemic-youth-e-cigarette-use
21. Agendas, Alternatives, and Public Policies, Second Edition, John W. Kingdon, with new foreword by James A. Thurber, pg. 124, para. 3 - This is an example of recombination of policy, in this case, the tobacco policy for cigarettes from the past is now being recombined to be applied to electronic cigarettes.
22. Juul Illegally Marketed E-Cigarettes, F.D.A. Says, https://www.nytimes.com/2019/09/09/health/vaping-juul-e-cigarettes-fda.html
23. Vaping-related illnesses surge as FDA discloses criminal probe, https://www.washingtonpost.com/health/2019/09/19/vaping-related-illnesses-surge-fda-announces-criminal-probe/
24. Does the FDA Even Regulate E-Cigs? Actually Kinda Not, https://www.wired.com/story/dangerous-levels-of-carcinogen-in-mint-flavored-vapes/
25. Deadly vape explosion highlights safety gaps, https://www.theverge.com/2019/2/5/18212603/deadly-vape-explosion-highlights-safety-gaps
26. Policy Paradox, The Art of Political Decision Making, Revised Edition, Deborah Stone, pg. 192, para. 2 - Stone speaks about how a policy that intends to do good ends up having harmful side effects, in this case, it may lead to people smoking cigarettes to acquire prescriptions for e-cigarettes which is an unintended side effect of a policy that was implemented to curb e-cigarette access in the first place.
27. Policy Paradox, The Art of Political Decision Making, Revised Edition, Deborah Stone, pg. 307, para. 2 - According to Stone, facts can be useful in resolving problems, raising educational campaigns will help people deliberate upon policies and decisions made by the government and hence be able to understand the policy better with the application of sheer logic and existing data.
28. Agendas, Alternatives, and Public Policies, Second Edition, John W. Kingdon, with new foreword by James A. Thurber, pg. 77, para. 3 - Kingdon speaks about the soil being fertile to push a certain policy, and the soil is fertile owing to the focusing events, feedback, numbers, national mood, etc. and so it is the perfect time to draft a policy for the same.
29. Policy Paradox, The Art of Political Decision Making, Revised Edition, Deborah Stone, pg. 232 - Stone speaks about making rational decisions and owing to these reasons, I think the reasons are enough to draw this up on to the agenda to form a decision model on how the steps would be implemented.